Senior Process Engineer - The Fountain Group
Fremont, CA
About the Job
Pay: $56.14/Hour
Description:
Skills:
Education:
Description:
- Evaluates, transfers, and implements new processes into the company’s Fremont GMP facility for the manufacturing of biopharmaceutical drug substance. This includes process transfers of internal company products and external contract manufacturing business (CMB) of client products into the multi-product facility.
- Provide scientific and technological support during process transfers, launch, and initial supply.
- Provide technical interface between at-scale manufacturing and the customer within a cross-functional project organization and supports deliverables with GMP/regulatory requirements.
- Responsible to provide direction, strategy, technical leadership, coaching of junior group members, and support for process troubleshooting, process/tech transfers and continuous improvement efforts for a large-scale bio-pharmaceutical manufacturing plant.
- Technical lead for at-scale manufacturing for assigned upstream and/or downstream processes of moderate complexity, inclusive of cell culture medium preparation, cell thaw, inoculum expansion, seed stage bioreactors, production bioreactors, and primary harvest with centrifuge and/or filtration, liquid chromatography, column packing, tangential flow and normal flow filtration, bulk formulation, filling, and freezing.
- Technical expert and liaison responsible for identification and implementation of at-scale manufacturing technology and improvements to effect positive change to our GMP manufacturing operations.
Skills:
- Experience with biopharmaceutical manufacturing processes, Project Management and Technical Writing.
- Experience with upstream and/or downstream bio-pharmaceutical manufacturing.
- Knowledge of aseptic processing, and benchtop in-process analytics, buffer preparation and storage for at-scale GMP manufacturing.
- Experience with technical writing and BLA filing.
Education:
- Bachelor’s Degree in Biochemical Engineering (or related field) with 6+ years of professional experience
Source : The Fountain Group
